June 23, 2025, Shenzhen – KeYe Life Sciences Ltd. announced  its independently developed Class I anti-cancer drug KY2 (an oral small-molecule inhibitor targeting RNA helicase DHX33) has received clinical trial clearance from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA), with approval number 2025LP01630. KY2, an oral small-molecule liquid capsule, represents the second drug candidate developed by KeYe Life to enter clinical trials.

KY2 previously obtained clinical trial clearance from the U.S. FDA. This CDE approval marks KY2's dual clearance in both China and the United States, initiating its global clinical development program.

Preclinical studies demonstrate that this oral small-molecule agent exhibits distinct tissue metabolism characteristics compared to intravenous formulations, suggesting differentiated clinical development pathways:
• Favorable human pharmacokinetic parameters
• Potent inhibition of tumor cell proliferation pathways
• Ability to overcome resistance to existing chemotherapy drugs
• Superior therapeutic safety window

KY2 is being developed for first-line and post-resistance treatment of advanced solid tumors, targeting a market potential exceeding US$10 billion.

No RNA helicase-targeting drugs are currently approved globally, making this protein family a highly anticipated therapeutic frontier. DHX33 is overexpressed in multiple human cancers and critically linked to tumorigenesis and progression, though target dependency varies across cancer types and individuals. KY2 has completed ethics pre-review at Shanghai Ruijin Hospital and will advance to Phase I clinical trials shortly, aiming to deliver a China-originated anti-cancer solution to global patients and ultimately bring new hope to those with advanced malignancies.